Purpose

The Tobacco Implementation Guide (TIG) Version 1.0 has been prepared by the Tobacco Implementation Guide team of the Clinical Data Interchange Standards Consortium (CDISC). The TIG v1.0 addresses concepts and endpoints for studies of tobacco products and translates them into CDISC standards to improve semantic understanding, support data sharing, and facilitate global regulatory submission. This implementation guide describes how to use CDISC standards for tobacco product studies and is intended to guide the organization, structure, and format of standard data collection, data tabulation, and analysis data submitted to a regulatory authority.

This guide applies to all products regulated by CTP and includes synthetic nicotine as well as any products deemed to be a tobacco product to include electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco, and nicotine gels.